Wed.Sep 04, 2024

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FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder

Drug Topics

DaylightRX from Big Health is a digital formulation of cognitive behavioral therapy and is available by prescription only.

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Tolebrutinib Shows Reduction in Disability Accumulation in Non-Relapsing Secondary Progressive Multiple Sclerosis

Pharmacy Times

In a promising development in multiple sclerosis research, tolebrutinib delayed the onset of disability progression in patients with nrSPMS.

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FDA Clears New Disposable Insulin Patch Pump For Patients With T1D and T2D

Drug Topics

Embecta’s new patch pump offers a larger insulin reservoir to better accommodate for the needs of patients with type 2 diabetes (T2D).

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Trying to time your seasonal vaccines just right? There are no easy answers, but here are some factors to consider

STAT

With fall coming into view, public health officials across the country are turning to the annual task of persuading legions of Americans to get vaccinated against some combination of influenza, Covid-19, and respiratory syncytial virus, three bugs that sicken mass numbers of people over the winter months, often overwhelming hospitals and health care delivery in the process.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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RedSail Technologies and the RxCash+ Tool

Drug Topics

Kristen Hartzell, PharmD, Vice President of Clinical Services, RedSail Technologies, sat down with Drug Topics to discuss the RxCash+ tool designed to achieve fairer pricing on cash prescriptions for pharmacies and patients.

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Moderna reports encouraging results on its mpox vaccine, as outbreaks in Africa spread

STAT

The emergence of a second mpox outbreak in which the virus is spreading from person-to-person, as well as a sharp increase in overall cases of the disease in several African countries, is straining the world’s capacity to make and distribute vaccine to battle the threat. New options are needed, and a study published Wednesday suggests another may be on the horizon.

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More Trending

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Inside the bruising battle to purge race from a kidney disease calculator

STAT

There it was on James Cannon’s lab report, two tiny words: African American. The words sat next to a number estimating how badly Cannon’s kidneys were failing. And they were definitely failing. His number read 37, less than half of what is considered normal for adults. Oddly, he thought, a different number labeled “if not African American” read even lower: 31.

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Bridging Health Equity: Addressing Heart Failure in Native American Communities

Pharmacy Times

New insights into heart failure risks in Native American communities are highlighting the need to address social determinants of health.

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Humana exiting Medicare Advantage in 13 markets

Fierce Healthcare

Humana reaffirmed its full-year guidance but is leaving 13 Medicare Advantage (MA) markets next year, Chief Financial Officer Susan Diamond said during the Wells Fargo Healthcare Conference on Wedn | Humana is pulling back from Medicare Advantage markets and cutting benefits next year. The insurer expects it will lose thousands of members and supplemental benefit utilization will be high toward the end of this year.

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Study: Birthing People With IDD Are Younger With Poorer Obstetric, Mental Health

Pharmacy Times

The findings demonstrate a need for additional health care provider training and resources for birthing people with intellectual and developmental disabilities.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Medicaid redeterminations still affecting Centene as stock plunges

Fierce Healthcare

Centene’s business is still impacted by Medicaid redeterminations, a process that began in early 2023, the company said during the Wells Fargo Healthcare Conference. | Centene's stock sunk Wednesday after the company highlighted issues it faces surrounding Medicaid redeterminations.

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Clinical Updates in Alirocumab Injection

Pharmacy Times

Alirocumab (Praluent; Regeneron), is a PCSK9 inhibitor indicated for the treatment of adults with heterozygous familiar hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease.

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STAT+: Humana cutting Medicare Advantage plans that cover 10% of members

STAT

Roughly 10% of people enrolled in Humana’s private Medicare plans will have to find new coverage for next year as the company trims its offerings in what’s become a turbulent corner of the industry.  Humana, the country’s second largest Medicare Advantage insurer, is aggressively culling its plan offerings after several quarters of spending more than expected on its members’ medical care, and getting hammered on Wall Street for it.

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FDA Grants Regenerative Medicine Advanced Therapy Designation for OBX-115

Pharmacy Times

OBX-115 could offer further treatment options for individuals with advanced or metastatic melanoma by enhancing persistence, antitumor activity, and clinical safety of TIL cell therapy.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Opinion: The Snoo can’t help the people who need it most

STAT

When you have a baby, sleep becomes the holy grail. You become convinced that getting your baby to go the hell to sleep depends on the right swaddles, the right pacifier, the right settings on the white noise machine, the right order of events. If a routine gets disrupted or a special object misplaced, you fear that the kid will be awake for days, and thus, so will you.

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Biogen to seek approval for high-dose version of SMA stalwart Spinraza after trial win

Fierce Pharma

Over the last decade, three blockbuster drugs—Biogen’s Spinraza, Roche’s Evrysdi and Novartis’ gene therapy Zolgensma—have transformed the treatment landscape for spinal muscular atrophy (SMA). | Biogen revealed that a portion of its phase 2/3 DEVOTE study met its primary endpoint, as a higher dose of Spinraza improved the motor function of treatment-naive infants with spinal muscular atrophy.

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Humana study: Senior-focused primary care can boost access, improve outcomes

Fierce Healthcare

Over the past several years, Humana has made significant strides in growing its senior-focused primary care business, and a new study highlights areas where it's seeing success in this model. | Over the past several years, Humana has made significant strides in growing its senior-focused primary care business, and a new study highlights areas where it's seeing success in this model.

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Astellas Gene Therapies to turn out the lights at South San Francisco production plant

Fierce Pharma

Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a Californ | Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a California production plant.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Leveraging Bioanalytical Studies Advancements

BioPharm

As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.

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Q&A: Turning Old Technology into Something New for Pharmaceutical Storage

Drug Topics

Dana Krug, Senior Vice President of Cold Chain Fulfillment at Phononic, explained the current state of his company’s cooling technology and the common trends of temperature control throughout the industry.

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Evernorth's Accredo to make Stelara biosimilar available at $0 out-of-pocket

Fierce Healthcare

Evernorth's Accredo specialty pharmacy will offer biosimilars for the popular immunotherapy Stelara at $0 for eligible patients, the company announced Thursday. | Evernorth's Accredo specialty pharmacy will offer biosimilars for the popular immunotherapy Stelara at $0 for eligible patients, the company announced Thursday.

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Digital Therapeutic Shows Significant Reduction in Episodic Migraine

Drug Topics

Click Therapeutics announced that CT-132 met its primary endpoint in the phase 3 ReMMi-D trial.

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Minimizing plastics use and risk in healthcare 

Fierce Healthcare

Microplastics are everywhere, including our bodies. | In this week's episode of "Podnosis," two experts break down the history of plastics use in the healthcare sector and what it would take for an organization to phase them out.

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Digital skills: Why private clinics need effective communication lines to bridge the growing digital divide

pharmaphorum

Digital skills: Why private clinics need effective communication lines to bridge the growing digital divide Mike.

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STAT+: Novartis to spend $200 million in further bid to boost radiopharma manufacturing, market dominance

STAT

Novartis is opening a new manufacturing facility in California and expanding an existing production site in its bid to dominate the booming radiopharmaceuticals field amid burgeoning competition. The pharmaceutical giant will spend more than $200 million to construct the new facility in Carlsbad, Calif., and expand its site in Indianapolis, representatives told STAT exclusively.

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DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continue

Fierce Pharma

With a shortage of ADHD drugs persisting, the DEA has raised production limits on Takeda’s Vyvanse and its generic versions by 24%, the agency said.

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How to relieve sinus pressure in your ears

The Checkup by Singlecare

Anyone who has ever woken up with a stuffy or runny nose has gone through the same thought process before getting up and reaching for a tissue: First, they hope it’s just the common cold or allergies. And second, they hope it’s not a sinus infection. Why? Unlike colds, which are caused by a virus and can be pesky but work themselves out in a day or two, sinus infections are bacterial and often stick around for ten days or more and come with symptoms like nasal congestion , postnasal drip , facia

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Roche trumpets new fenebrutinib data in relapsing MS

pharmaphorum

Data from a phase 2 trial of Roche's oral BTK inhibitor fenebrutinib have shown "near-complete suppression" of disease activity and disability progression in relapsing multiple sclerosis (MS).The full results of the FENopta open-label extension study are due to be reported in full at the ECTRIMS congress in Copenhagen later this month, but top-line findings include that 99% of patients treated with fenebrutinib were free of T1 gadolinium-enhancing lesions, markers of active inflammation, at 48 w

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Actimed’s ALS candidate wins FDA orphan drug designation

Pharmaceutical Technology

Actimed says S-oxprenolol shares a similar pharmacology to its lead product S-pindolol, which is being studied in cachexia.

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Pharma Pulse 9/4/24: How Do You Change a Chatbot’s Mind? Understanding the Current State of M&A & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Pharma’s ‘it’ therapy — a new drug class gaining steam

PharmaVoice

More companies are investing in protein degraders, which leverage a unique approach to harnessing the immune system in cancer, neurological diseases and more.

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EC approves Merck’s KEYTRUDA-Padcev combo for urothelial cancer

Pharmaceutical Technology

Merck has gained EC approval for KEYTRUDA plus Padcev for adults with unresectable or metastatic urothelial carcinoma.

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Depression: How brain scans helped predict long-term treatment outcomes

STAT

Depression has many faces. Some people can’t sleep, while others struggle to get out of bed. Even though symptoms and severity can vary from person to person, a recent study found that a specific brain circuit might be associated with the mental malady.  Located in the prefrontal cortex, the brain’s cognitive control circuit plays a part in our attention, goal-setting behavior and other executive functioning.

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